Autism Spectrum Disorder, EEG With Periodic Abnormalities, Epilepsy, Neurodevelopmental Disorders, Neurological Disorder
Conditions
Keywords
Autism, Epilepsy, Neurological Disorders, Neurodevelopmental disorders, ASD
Brief summary
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or with epilepsy. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.
Interventions
DEVICEnoninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
The proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.
Sponsors
Richard Frye
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, open label study including 15 individuals with active seizures and 15 individuals with EEG abnormalities who will receive the same near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R). * Between 4 and 12 years of age, at baseline. * Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment. * Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period. * Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry * Ability to tolerate procedures, as determined at the discretion of the investigator. * At least one 24hr EEG with data in EDF format that is accessible to investigators.
Exclusion criteria
* Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior * Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill) * Severe prematurity (\<34 weeks gestation) as determined by medical history * Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures * Genetic syndromes * Congenital brain malformations * Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data. * Failure to thrive or Body Mass Index \< 5%ile or \<5%ile for weight (male \<11.2kg; female \<10.8kg by CDC 2000 growth charts) at the time of the study. * Concurrent treatment with drug that would significantly interact with treatment. * • Stimulants * • Anti-Psychotics * • Antihistamines * Excessive Hair that the caregivers are unwilling or unable to shave or braid. * Inability to tolerate the required dosage of tPBM treatment due to sensory issues.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Childhood Autism Rating Scores (CARS) | Baseline, Week 5, Week 11 and Week 15 (One Month Follow-Up) | The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG Delta Power | Before Treatment and EEG following treatment (within 6 months) | Delta power is a measures of the amount of brain activity in the delta frequency as measured by overnight EEG |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRichard E Frye, M.D., Ph.D
Rossignol Medical Center, Phoenix AZ
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 8.1 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 5 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
None listed